pharmaceutical compliance congress
pharmaceutical compliance congress
pharmaceutical compliance congress
pharmaceutical compliance congress
pharmaceutical compliance congress
pharmaceutical compliance congress



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    Day III: Pharma Congress
    Friday, October 21, 2016





    CLOSED SESSION: INDUSTRY-ONLY COMPLIANCE BEST PRACTICES THINK TANK







(Industry-only Session for Pharmaceutical Company Ethics and Compliance Professionals and In-house Counsel Only)



8:30 a.m.





Introductions and Antitrust Admonition

Matthew D'Ambrosio, JD, MBA
Senior Vice President, Chief Compliance and Ethics Officer, Sunovion Pharmaceuticals Inc., Marlborough, MA (Co-chair)

    Speaker Bio

    Matthew D'Ambrosio is currently Senior Vice President, Chief Compliance and Ethics Officer at Sunovion Pharmaceuticals Inc.

    Prior to joining Sunovion, Mr. D'Ambrosio served as Vice President, U.S. Legal Affairs and Chief Compliance Officer at Prostrakan, Inc.

    Previously, Mr. D'Ambrosio served as Chief Compliance Officer for Reliant Pharmaceuticals, Inc., one of the country's largest privately-held pharmaceutical companies which was acquired by GSK in 2007. He began his career with Johnson & Johnson where he headed compliance programs in each of J&J's three core sectors: Pharmaceuticals, Medical Device & Diagnostics and Consumer Products

    Mr. D'Ambrosio was previously adjunct faculty at Seton Hall Law in the Health Law Program.






James Gibney
Senior Director of Compliance, Regeneron Pharmaceuticals; Former Director, Worldwide Programs and US Investigations - Corporate Compliance, Pfizer, Tarrytown, NY (Co-chair)

    Speaker Bio

    Jim Gibney is Senior Director, Corporate Compliance. Jim and his team are responsible for leading efforts to enhance and manage various elements of an effective compliance program. Responsibilities include policy development, developing and delivering company-wide compliance training, Global, Federal and State aggregate spend reporting, executing a compliance communication strategy, and providing Compliance related support to Regeneron's various business functions.

    Jim began his career at Pfizer in 1992 and has held various positions in sales, operations, and compliance.

    Jim served 9 years in the United States Naval Reserve and is a graduate of Rutgers University.






Jeffrey Kawalek, MBA
Associate Director, Compliance Risk, Novo Nordisk, New York, NY (Co-chair)

    Speaker Bio

    Jeffrey Kawalek is a compliance professional with seventeen years of pharmaceutical experience with a focus on developing and implementing effective pharmaceutical compliance programs, mitigating risk, and advancing compliance with Company policy and Federal and state healthcare laws.

    Jeff has worked at Novo Nordisk since 2007 and has supported the Chief Compliance Officer to set and accomplish the strategic objectives of the corporate compliance program. He has contributed to the development of the compliance program and has had responsibilities leading various functions including: Federal [Sunshine] Open Payments and state reporting, monitor and auditing, risk management, and components of the Corporate Integrity Agreement. He has also supported several global compliance initiatives.

    He holds a Bachelors Degree in Business Administration from The University of Delaware and an MBA from the Fox School of Business at Temple University.






Glenna Shen, JD, MBT
Executive Director, Worldwide Compliance and Business Ethics, Amgen Inc., Thousand Oaks, CA (Co-chair)

    Speaker Bio

    Glenna Shen is Executive Director, Compliance with responsibility for the US Business and Global Functions at Amgen. Ms. Shen joined Amgen in 2000, and has held various positions in the Law Department and with Worldwide Compliance and Business Ethics, most recently heading up the Compliance function at Onyx Pharmaceuticals, and Amgen subsidiary. Ms. Shen obtained her Bachelor of Arts degree in Biology from the University of Miami and her Juris Doctor and Master of Business Taxation from the University of Southern California.










8:30 a.m.





Update from PhRMA

John Murphy, JD
Assistant General Counsel, Pharmaceutical Research and Manufacturers of America (PhRMA), Washington, DC

    Speaker Bio

    John Murphy is the Assistant General Counsel of the Pharmaceutical Research and Manufacturers of America (PhRMA), a trade association representing innovative biopharmaceutical research and discovery companies. Mr. Murphy's responsibilities include serving as legal advisor to the Organization's state advocacy, government relations, and policy sections, as well as coordinating legal and advocacy policy on the Organization's health reform initiatives.










10:00 a.m.



Break










10:30 a.m.



Facilitated Small Group Best Practice Sharing on Key Topics










12:00 p.m.



Congress Adjournment













ATTENDANCE OF CLOSED SESSIONS LIMITED

As noted above, attendance in the closed session is limited to company compliance professionals and in-house counsel only. The purpose of the closed session is to permit the attendees to engage in a more focused exchange of views regarding issue priority and best compliance practices. Upon registration, attendees will indicate if they plan to attend the closed session. If there is a question raised regarding qualification to attend the closed session, a member of the Congress planning committee will make the final determination.




Go to Agenda:
Preconferences / Day 1 | Day 2




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